Cancer and Leukemia Group B



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Date: October 10, 2013

To: Experimental Therapeutics Committee

From: Charles Erlichman, MD and Gary Schwartz, MD

Re: Experimental Therapeutics Committee Meeting

Friday, November 8, 2013

Time: 8AM-11AM CST

Location: TBD (per agenda for the Alliance mtg)

Call In Information: 800-501-8979 / 8087368

AGENDA

1. Status update on activated current trials: (appx. 60 min) Horvath

|a. |A091104 |Phase II MK-2206 in Patients with progressive recurrent/metastatic Adenoid Cystic |A. Ho |

| | |Carcinoma | |

|b. |A091103 |Phase 2 Study of Angiopoitein -1 and -2 peptibody AMG386 for the Treatment of |S. D'Angelo |

| | |Angiosarcoma | |

|c. |A091102 |Phase II study of MLN8237 in advanced metastatic Sarcoma |M. Dickson |

|d. |A091101 |TPF Induction chemotherapy and ABT-888- Phase 1/randomized Phase 2 Study in |J. de Souza |

| | |Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck| |

|e. |N1153 |Phase I/II Study of Sorafenib + TH-302 in 1st line Advanced Hepatocellular |M. Borad |

| | |Carcinoma (HCC) and 2nd line Renal Cell Carcinoma (RCC) | |

|f. |N0871 |A Phase II Study of Carboplatin, Paclitaxel, and RAD001 in previously untreated |M. Goetz |

| | |Patients with Measurable Disease with Cancer of Unknown Primary (CUP) | |

|g. |N0879 |A Randomized Phase II Trial of Carboplatin, Paclitaxel, Bevacizumab, with or |R. McWilliams |

| | |without Everolimus for Therapy of Metastatic Malignant Melanoma | |

|h. |N0185 |A Phase I/Feasibility Study of RAD001 plus R-CHOP for New Untreated Aggressive |P. Johnston |

| | |Lymphoma | |

|i. |A091201 |Randomized Phase II study comparing the MET Inhibitor XL184 to DTIC in Uveal |J. Luke |

| | |Melanoma | |

2. Status update on current trials in development: (appx. 40 min) Schwartz or Horvath

|a. |A091105 |Phase 3 double blind randomized placebo controlled trial of Sorafenib in Desmoid |M. Gounder |

| | |Tumors | |

|b. |A091302 |Randomized Phase II study of Sorafenib with or without Everolimus in Patients with|E. Sherman |

| | |Radioactive Iodine Refractory Hürthle Cell Thyroid Cancer | |

|c. | A091305 |A Phase 2 Double-Blind Randomized Study of Efatutazone, an Oral PPAR Agonist, in |R. Smallridge |

| | |Combination with Paclitaxel versus Paclitaxel Plus Placebo in Patients with | |

| | |Advanced Anaplastic Thyroid Cancer | |

|d. | A091303 | A Randomized Double-Blinded Phase 3 Study of Palbociclib (PD0332991) in |M. Dickson |

| | |Well-differentiated / De-differentiated Liposarcoma | |

|e. |A091202 |A Phase II Randomized Study of the Peroxisome Proliferator-Activated Receptor |M. Pishvaian (GW) |

| | |Gamma Agonist, CS-7017 (Efatutazone) vs. Placebo in Patients with Previously | |

| | |Treated, Unresectable Myxoid Liposarcoma | |

3. Status of Concepts: (appx. 20 min) Erlichman

|a. |Randomized Phase 2 study of chemo and androgen ablation in salivary gland cancer EORTC 1206 |Ho (MSK) |

|b. |A Randomized Phase II Study of MLN-0128 vs. Pazopanib in Patients with Advanced Sarcoma |W. Tap |

4. New Concepts (appx. 40 min) Schwartz/Erlichman

|a. |Treatment of Melanoma |J. Luke |

5. Central Office updates: Accrual committee, International Committee, Grant results - Horvath (appx 20min)

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Charles Erlichman, MD, FRCPC, FACP

Co-Director for Experimental Therapeutics Committee

Mayo Clinic

200 First Street SW

Rochester, MN 55905

Phone: 507-266-3200

Email: Erlichman.charles@mayo.edu

Gary Schwartz, MD

Co-Director for Experimental Therapeutics Committee

Memorial Sloan-Kettering Cancer Center

300 East 66th St

New York, NY 10065

Phone: 646-888-4158 Email: schwartg@

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